FDA grants Plan B contraceptive OTC status

Prescription still required for women under 18

CarolynPritchard

SAN FRANCISCO (Marketwatch) -- The Food and Drug Administration on Thursday granted over-the-counter status to Barr Pharmaceuticals Inc.'s Plan B emergency contraceptive, three years after an agency advisory panel recommended the decision.

Two Democratic senators promptly lifted their blockade on President Bush's nominee for FDA head, Dr. Andrew von Eschenbach. His confirmation is now expected to take place next month.

Numerous lawmakers have accused the regulatory agency and the Bush administration with continually delaying a decision on whether or not to make the so-called "morning-after pill" available without a prescription in an effort to placate conservatives, a charge FDA officials have denied.

The pill, known as Plan B, contains an ingredient used in prescription birth-control pills, but at a higher dosage and with a different dosage regimen. Given that it's supposed to be taken within 72 hours after unprotected sex, some have argued it is akin to abortion. Others have maintained that over-the-counter sales would encourage risky sexual behavior amongst teenagers.

The pill has been available through a prescription since 1999. An FDA advisory panel backed putting it up for sale without a prescription in 2003, and although the agency almost always follows the recommendations of its advisory panel, it continued to delay a decision on Plan B's OTC status. Finally, in 2005, then-FDA Commissioner Lester Crawford said the agency would issue a final decision on by Sept. 1. of that year.

But days before the deadline, the FDA said that while it saw a scientific basis for allowing over-the-counter sales for women 17 or older, it would have to hold public hearings on the issue before it could render a formal decision. Three weeks later, Crawford abruptly resigned, and the White House named von Eschenbach, director of the National Cancer Institute, acting commissioner. See full story.

This spring, Bush nominated von Eschenbach to head the FDA.

On July 31, one day before von Eschenbach's confirmation hearings, the agency and Barr Pharma
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announced they would meet within a week to review the OTC application. Sens. Patty Murray, D-Wash., and Hillary Clinton, D-N.Y. called the announcement "nothing more than another delay tactic" and said they would continue to block von Eschenbach's nomination until a decision on Plan B was rendered.

On Thursday, the FDA signed off on making the pill available over-the-counter to women 18 years and older; a prescription will still be required for anyone younger. It will be available at retail pharmacy outlets and clinics with professional health-care supervision.

Barr has also agreed to implement a program to ensure that the pill is only dispensed under terms of the FDA's approval through what the agency called "a rigorous labeling, packaging, education, distribution and monitoring program."

Calling the FDA's decision long overdue and urging it to revisit the age restriction, Sens. Murray and Clinton lifted their blockade. "As promised, we will lift our hold on the nomination of acting FDA Administrator von Eschenbach and hope that he will provide the strong scientific leadership the FDA needs and deserves," the senators said in a joint statement.

Barr vowed to continue trying to get the FDA to lower the OTC age restriction, saying it still feels the pill should be available without a prescription to a "broader age group."

Planned Parenthood hailed the FDA's decision, but said it was troubled by what it called "the scientifically baseless restriction imposed on teenagers."

"The U.S. has one of the highest rates of teen pregnancy in the western world -- anything that makes it harder for teenagers to avoid unintended pregnancy is bad medicine and bad public policy," President Cecile Richards said in a statement.

Faith-based organizations that claim to promote family values, however, were furious. The Family Research Council called the FDA's decision "outrageous" and said it was pursuing legal and legislative options against the agency.

"An agency charged with protecting the health interests of the country must be held to high standards of accountability," President Tony Perkins said in a statement. "Congress must respond to this outrageous action by the FDA."

Focus on the Family called Plan B's OTC status, regardless of the age requirement, "an invitation for adult men to pressure underage girls to have sex with the promise of an easily accessible magic pill to prevent or abort a pregnancy," according to a statement.

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